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Comparative Performance of PureVision, Acuvue Oasys and O2Optix

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00640341
First received: February 20, 2008
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.


Condition Intervention Phase
Myopia
 Device: PureVision Contact Lens
Device: Acuvue Oasys Contact Lens
Device: O2Optix Contact lens
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Any Slit Lamp Finding > Grade 2 [ Time Frame: Over all follow-up visits for the 1 month study period ] [ Designated as safety issue: No ]
    All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.

  • Subjective Responses to Comfort-related Symptoms/Complaints [ Time Frame: Over all follow-up visits for 1 month study period ] [ Designated as safety issue: No ]
    Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.

  • Uncorrected Distance High Contrast Visual Acuity [ Time Frame: Over all visits for the 1 month study period ] [ Designated as safety issue: No ]
    logMAR high contrast visual acuity (VA) over all visits.


Enrollment: 510
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PureVision
PureVision Contact Lens
 Device: PureVision Contact Lens
contact lens for daily wear
Active Comparator: Acuvue Oasys
Acuvue Oasys Contact Lens
 Device: Acuvue Oasys Contact Lens
contact lens for daily wear
Active Comparator: O2Optix
O2Optix Contact Lens
 Device: O2Optix Contact lens
contact lens for daily wear

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is myopic
  • VA correctable to 0.3 LogMAR or better (driving vision)
  • Clear central cornea
  • Subject uses a lens care system on a regular basis

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • Using systemic or topical medications
  • Wear monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640341

Locations
United States, Florida
Anderson & Associates
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Gerard Cairns, MCOptom, PhD Bausch & Lomb Incorporated
Principal Investigator: Bruce Anderson, OD Anderson & Associates
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00640341     History of Changes
Other Study ID Numbers: 552
Study First Received: February 20, 2008
Results First Received: February 3, 2011
Last Updated: December 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013